|
|
| |||||||||
|
MEDIA CENTER Spray-on contraception The Population Council granted to Acrux a worldwide license to intellectual property covering the use of Nestorone® (NES) with the Metered Dose Transdermal System (MDTS®) so that the pharmaceutical firm can further develop and commercialize Nestorone MDTS. MDTS is a hand-held aerosol drug delivery system. The spray, delivered via a MDTS, would be painless, easy to use, and convenient. The spray contains Nestorone, a versatile synthetic progestin closely resembling the natural hormone progesterone. Studies have shown that NES works like other hormonal methods, such as the pill, by inhibiting ovulation and thus preventing fertilization. The drug would be administered once per day. The spray would most likely be used on the woman’s forearm. Users of NES MDTS simply push a button and wait about one minute for the spray to dry. The NES MDTS is expected to be relatively low-cost. A Phase 1, proof-of-concept, pharmacokinetic study conducted in six healthy women was completed in 2005. The research was conducted at the Sydney Centre for Reproductive Health Research in New South Wales, Australia. The results showed that once-a-day dose of the spray provided sustained delivery of the contraceptive agent Nestorone. Mean serum concentrations of Nestorone were maintained in the target range expected to be effective for contraception. The spray was well tolerated, with no serious adverse events recorded. Ian Stewart Fraser, professor in reproductive medicine at the University of Sydney, Australia, and a member of the Population Council's International Center for Contraception Research, was a co-principal investigator for the Phase 1 trial. A Phase 2 trial, scheduled to begin in the second half of 2006, aims to demonstrate that the NES MDTS spray inhibits ovulation. The testing could result in the first-ever contraceptive delivered by a spray, giving women around the world another option for managing their fertility. The spray has the potential to be at the cutting edge of healthcare options for women. The Acrux spray technology has been used by millions of people for more than two decades as a safe, non-irritating, drug delivery system. The Population Council Biomedical research at the Population Council Scientists also explore the treatment of diseases of the reproductive system, such as prostate cancer, and are addressing hormonal problems associated with aging in men and women. A primary activity of staff members is applied research, including the development of new methods of contraception to meet the needs of women and men. The Council has already delivered to market:
Acrux Limited Acrux’s product pipeline includes treatments of hormonal deficiencies, pain, central nervous system disorders, and a contraceptive. Twenty human clinical trials have been completed with eight different drugs, and the lead product, Evamist™, is nearing the end of a Phase 3 trial in the United States. Acrux has licensed the US rights for Evamist (Estradiol MDTS®) and Testosterone MDTS® to VIVUS and AUS/NZ distribution rights for Testosterone MDTS and Fentanyl UDTS™ to CSL Limited. Acrux has also licensed its technology to Eli Lilly for veterinary healthcare products.
|
|
|
|||||||
